Randomised trial of a parent-mediated intervention for infants at high risk for autism: longitudinal outcomes to age 3 years

Background: There has been increasing interest in the potential for pre-emptive interventions in the prodrome of autism, but little investigation as to their effect. Methods:A two-site, two-arm assessor-blinded randomised controlled trial (RCT) of a 12-session parent-mediated social communication intervention delivered between 9 and 14months of age (Intervention in the British Autism Study of Infant Siblings-Video Interaction for Promoting Positive Parenting), against no intervention. Fifty-four infants (28 intervention, 26 nonintervention) at familial risk of autism but not otherwise selected for developmental atypicality were assessed at 9-month baseline, 15-month treatment endpoint, and 27- and 39-month follow-up. Primary outcome: severity of autism prodromal symptoms, blind-rated on Autism Observation Schedule for Infants or Autism Diagnostic Observation Schedule 2nd Edition across the four assessment points. Secondary outcomes: blind-rated parent-child interaction and child language; nonblind parent-rated communication and socialisation. Prespecified intention-to-treat analysis combined estimates from repeated measures within correlated regressions to estimate the overall effect of the infancy intervention over time. Results: Effect estimates in favour of intervention on autism prodromal symptoms, maximal at 27months, had confidence intervals (CIs) at each separate time point including the null, but showed a significant overall effect over the course of the intervention and follow-up period (effect size [ES]=0.32; 95% CI 0.04, 0.60; p=.026). Effects on proximal intervention targets of parent nondirectiveness/synchrony (ES=0.33; CI 0.04, 0.63; p=.013) and child attentiveness/communication initiation (ES=0.36; 95% CI 0.04, 0.68; p=.015) showed similar results. There was no effect on categorical diagnostic outcome or formal language measures. Conclusions: Follow-up to 3years of the first RCT of a very early social communication intervention for infants at familial risk of developing autism has shown a treatment effect, extending 24months after intervention end, to reduce the overall severity of autism prodromal symptoms and enhance parent-child dyadic social communication over this period. We highlight the value of extended follow-up and repeat assessment for early intervention trials.